Three Registration Pathways for Medical Devices in Argentina

1. Key takeaways

After Argentina’s 2025 regulatory reform, product registration follows three risk-based pathways, and the classification outcome of a device determines which pathway applies. The pathway, in turn, determines the depth of technical documentation, the review timeline, and the intensity of regulatory scrutiny an application will face, so identifying the correct route is the single most consequential decision in any Argentina market-entry plan. The three pathways are:

1. Sworn declaration (Declaración Jurada) — applicable only to the narrowest band of low-risk products: non-sterile, non-measuring, non-active Class I devices that are also listed in the relevant official list. A sworn declaration signed before the INPM is itself treated as the registration instrument, and no separate review-based certificate is issued.
2. Declaration of conformity (Declaración de Conformidad) — applicable to all remaining Class I devices and to all Class II devices. The INPM examines the sworn documents submitted by the applicant; once signed, the declaration is treated as the registration instrument, without a full technical review.
3. Conventional registration (full technical review) — applicable to Class III / IV devices. A complete technical dossier is submitted, ANMAT conducts a full technical review, and upon approval the registration is granted by administrative act and a PM registration number is assigned.

For in vitro diagnostics the structure maps onto the same logic under Disposición ANMAT 2198/2022: Group A/B reagents proceed through the declaration of conformity, while Group C/D reagents require the full review pathway. The two simplified routes are not an Argentine innovation — GMC 25/21 expressly authorizes member states to apply simplified procedures to Class I and Class II devices, and Argentina implemented the two fast-track routes on that basis.

Before choosing a route, note that the three pathways differ in more than review depth. The sworn declaration route dispenses with a substantive examination almost entirely but is confined to the narrowest product band; the declaration of conformity adds an INPM examination of the sworn documents; and the conventional route subjects the dossier to full technical review and ends in an administrative act with a PM registration number. Because the classification decision drives everything downstream, it should be made — and documented — before any filing strategy is discussed, and revisited whenever the product or its intended use changes.

2. Legal basis

The instruments below define the three pathways, their scope, and the simplified procedures they authorize.

3. Expert insights

Insight 1: the dividing line among the three pathways is not which route the company prefers, but which route the classification outcome dictates. The sworn declaration and the declaration of conformity are available only where the classification conclusion falls within Class I/II and the additional conditions are met. If a company artificially downgrades its classification to reach a fast-track route and the INPM identifies this during its examination, the application will not only be redirected to the conventional route — an unfavorable record will also remain in the regulatory file.

Insight 2: no full technical review does not mean no technical documentation. The INPM still examines the sworn documents, and the company must retain a complete technical dossier for inspection — this is one of the statutory duties of the registration holder. What the simplified pathways reduce is the depth of review, not the documentation obligation. Teams that treat the fast-track routes as documentation-free routinely fail later inspections.

Insight 3: a fourth channel is layered on top from 2026. Disposición 236/2026 establishes a prior sworn notification regime at the import and commercialization stage for Class I/II devices and for Group A/B IVD that do not require cold chain. It runs in parallel with product registration: the product still must complete registration (or a declaration), but the import stage no longer requires batch-by-batch prior approval. The two mechanisms cannot substitute for each other.

Pathway selection also has downstream consequences that are easy to underestimate. The pathway chosen at filing determines what the post-market dossier must look like, what inspectors will ask for, and how changes to the product will be processed later. A device that entered through a simplified route still faces the same local holder duties, the same vigilance obligations and the same import-stage mechanics as any other product. The recommendations below therefore focus on making the pathway decision defensible and on keeping the documentation posture consistent with it.

4. Practical recommendations

1. Lock the pathway in three steps: classification → additional conditions → pathway. Reach the classification conclusion first, then verify whether the device is non-sterile, non-measuring, non-active and listed in the relevant list, and only then fix the pathway. Record all three conclusions in a written document.
2. Prepare documentation to full-dossier standard even under a simplified route. Assemble the technical report, the risk management report, the ISO 13485 certificate and Spanish-language labeling as a complete set, and archive it locally to withstand post-market inspection.
3. Assess IVDs separately. Reagents are not subject to the 22-rule device classification; they must be grouped under Disposición 2198/2022 and then mapped to the Group A/B or Group C/D route.
4. Plan the import stage in parallel. Once the product registration pathway is fixed, immediately check Disposición 4446/2025 and 236/2026 to confirm whether the import stage requires prior authorization or subsequent notification.

5. Verification checklist

Use the following checklist to confirm that the pathway decision is complete and defensible.

• □ The classification conclusion has been fixed in writing with supporting justification
• □ It has been verified whether the Class I device is non-sterile, non-measuring, non-active and listed in the relevant list
• □ The specific pathway — sworn declaration, declaration of conformity, or conventional registration — has been determined
• □ IVD products have been grouped under 2198/2022 and mapped to a pathway
• □ The complete technical dossier has been prepared and archived locally under the simplified route
• □ The authorization/notification requirements at the import stage have been confirmed in parallel

A final cross-check helps before the pathway decision is released to the project team: compare the pathway conclusion against the classification dossier, confirm the IVD grouping where relevant, and confirm that the import-stage instrument has been identified by number. If any of the three cannot be answered in a single sentence, the pathway decision is not yet ready to support a filing calendar.

Regulatory information verified as of October 29, 2026.

In Argentina, GRZAN operates a wholly-owned subsidiary that can act as the registration holder and importer for foreign manufacturers, directly handling classification assessment, pathway selection, GMP and CFS documentation chains, Spanish-language technical documentation and labeling localization, HELENA submissions and deficiency responses, as well as BONITA import notifications, ARGOS vigilance system operation, change maintenance and 5-year renewal planning.

The GRZAN regulatory team consists of professionals with many years of hands-on international registration experience and tracks the developments of regulatory authorities worldwide. All published content follows the drafting standard of conclusions first, traceable legal basis, and verifiable figures. For an Argentina or MERCOSUR market-access plan tailored to a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.